The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule

Overview

This trial is active, not recruiting.

high dose group of sailuotong capsule, low dose group of sailuotong, the control group

Phase

phase 2

Sponsor

Shineway Pharmaceutical Co.,Ltd

Start date

December 2011

End date

July 2014

Trial size

372 participants

Trial identifier

NCT01978730, SW001

Summary

As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial
effects on learning and memory ability in animal models of vascular dementia (VaD). The
study hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients
with VaD and will be well tolerated. The purpose of the study is to determine the efficacy
and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures
include general cognitive function, executive function, daily living skills, and mental
behavior changes of symptoms in VaD patients.

take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.

low dose group of sailuotong

low dose group of SaiLuoTong capsule: take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.

The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day.

the control group

The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day.

Primary Outcomes

Measure

V-ADAS-cog

time frame:
weeks 0, 13, 26, 39, and 52

ADCS-CGIC

time frame:
weeks 0, 13, 26, 39, and 52

Secondary Outcomes

Measure

ADCS - ADL

time frame:
weeks 0, 26, and 52

MMSE

time frame:
screening, weeks 0, 26, and 52

CDR scale

time frame:
screening, weeks 0, 26, and 52

CLOX

time frame:
weeks 0, 26, and 52

C-EXIT25

time frame:
weeks 0, 26, and 52

NPI

time frame:
weeks 0, 26, and 52

CDR-sb

time frame:
weeks 0, 26, and 52

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria:
- 40 years old or above, gender is not limited;
- Education≥primary-school;
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental
Disorders-4th Edition (DSM-IV) criteria;
- Probable VaD diagnosed by the National Institute of Neurological Disorders and
Stroke-Association Internationale pour la Recherche et l'Enseignement en
Neurosciences(NINDS-AIREN) criteria;
- Modified Hachinski ischemic scale(MHIS) total score≥4;
- Evidence of ischemic cerebrovascular disease on magnetic resonance imaging (MRI)and
/or CT (corresponding with the imaging criteria of NINDS-AIREN)
- Mild-to-moderate dementia defined by MMSE score between 10 and 26, CDR score between
1 and 2, both inclusive
- Modified Hachinski ischemic scale(MHIS) total score≥4;
- Hamilton depression scale (HAMD) total score≤17;
- The patients agree to participate in the study and able to understand informed
consent as well as signing it. In cases where patients are unable to do so, carer's
consent will be obtained as proxy;
- There are carers accompanying patients at least 4 days a week and can accompany
patients to participate in each visit.
Exclusion Criteria:
- Dementia caused by other brain diseases except VaD (e.g. Alzheimer's disease, Lewy
body dementia, frontotemporal dementia, Parkinson's disease, demyelinated disease of
the central nervous system, tumour, hydrocephalus, head injury, central nervous
system infection including syphilis, acquired immune deficiency syndrome, etc.);
- The patient who can not complete examination because of severe brain or nerve
function loss, such as convenient hand hemiplegia, all sorts of aphasia and
audio-visual obstacles, etc;
- The presence of abnormal laboratory parameters: Hemoglobin (Hb) and platelet
(Plt)less than the lower limit; activated partial thromboplastin time (APTT) beyond
the normal value more than 10 seconds, prothrombin time (PT) beyond the normal value
more than 3 seconds; creatinine (Cr) more than 1.5 times the upper limit value;
alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of
normal, total bilirubin (TBiL) more than 1.5 times the upper limit of normal;
- Nutrition metabolic diseases and endocrine system lesions such as thyroid disease,
parathyroid diseases,and deficiency of vitamins or other elements;
- Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases
(such as unstable angina, incontrollable asthma, active bleeding, etc.) and cancer;
- Severe mental illness (such as depression, schizophrenia) and epilepsy;
- Gastrointestinal disorders that affect drug absorption, distribution, and metabolism;
- Alcohol and drug abuse;
- Patients who are using and cannot stop the following drugs including Chinese herba
preparation containing ginseng, ginkgo leaf or any component of the saffron;
medications that may affect cognitive functioning, such as donepezil, rivastigmine,
huperzine A, memantine, nimodipine; etc.;
- Known to be allergic to the composition of SaiLuoTong;
- Pregnancy or breast-feeding women;
- New strokes within 3 months before baseline
- Had participated in other clinical trials before this study 3 months prior to this
study.

Vascular dementia (VaD) is a clinical syndrome of acquired intellectual and functional
impairment that results from cerebrovascular diseases. SaiLuoTong capsule is a traditional
Chinese medicine compound; it is composed of ginseng extract (the main composition: ginseng
total saponins), ginkgo biloba extract (the main composition: YinXingTong ester) and
safflower extract (the main composition: the west safflower total glycosides). The function
of SaiLuoTong capsule is Yiqi Huoxue and Huayu Tongluo in Chinese traditional medicine
theory. Pharmacodynamics studies showed that SaiLuoTong capsule can significantly improve
neurological symptoms caused by focal cerebral ischemia in animals, and learning and memory
ability in animal models of VaD. Based on these previous evidences, we conduct this study to
assess the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD.
This study is a phase 2 clinical trial of SaiLuoTong capsule for treatment of vascular
dementia. The initial study is a 26-week, multicentre, randomized, double -blind,
placebo-controlled study. Patients who complete the initial 26-week trial will be eligible
to continue in a 26-week open-label extension study.
The primary and secondary objectives of this study are as following:
Primary Objectives:
1. To assess the efficacy of SaiLuoTong capsule on cognitive and global functioning in
patients with mild-to-moderate VaD;
2. To assess the safety and tolerability of SaiLuoTong capsule in patients with
mild-to-moderate VaD.
Secondary Objectives:
1. To assess the efficacy of SaiLuoTong capsule in improving the ability to do activities
of daily living, executive function, and neuropsychiatric symptoms in patients with
mild-to-moderate VaD;
2. To assess the efficacy of different dosage regimens of SaiLuoTong in patients with
mild-to-moderate VaD;
3. To assess the efficacy of SaiLuoTong treatment of different duration in patients with
mild-to-moderate VaD;
4. To assess the efficacy of SaiLuoTong capsule on different etiological subtypes of VaD,
including large-vessel VaD, small-vessel VaD, and VaD of mixed large-vessel and
small-vessel origin;
5. To assess the efficacy of SaiLuoTong capsule in mild VaD patients and moderate VaD
patients separately;
6. To assess to effect of apolipoprotein E (ApoE) ε4 allele on trial outcomes.
The study will assess the changes in cognitive function, daily living skills, executive
functions, behavioral and psychological symptoms. The primary measures of effectiveness
include the change from baseline in the vascular dementia assessment scale cognitive
subscale (V-ADAS-cog) and Alzheimer's disease cooperative study-clinical global impression
of change (ADCS-CGIC). Secondary measures of effectiveness include the change from baseline
in the Alzheimer's disease cooperative study-activities of daily living inventory
(ADCS-ADL), mini-mental state examination (MMSE), clinical dementia rating scale (CDR), sum
of boxes of CDR(CDR-sb), clock drawing task (CLOX), Chinese version of executive interview
25 (C-EXIT25) and neuropsychiatric inventory (NPI). Safety measures include physical
examinations, vital signs, electrocardiography, laboratory tests, and adverse events
records.